Change From Baseline in Mean Migraine Headache Rates During the Entire 14-week Maintenance Period [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

Secondary Outcome Measures:

Change From Baseline in Mean Migraine Headache Rates During the Last 4 Weeks of the Maintenance Period [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Entire 14-week Maintenance Period. [ Time Frame: Baseline, Entire 14-week Maintenance Period ]

Number of Subjects Who Experience a 50 Percent or Greater Reduction From Baseline in Migraine Frequency During the Last 4 Weeks of the Maintenance Period. [ Time Frame: Baseline, last 4 weeks of the 14-week Maintenance Period ]

Changes From Baseline in Improvement of Function and Reduction of Disability Using the Headache Impact Test (HIT-6) [ Time Frame: Baseline, last visit in the 17-week Trial Period ]

Headache Impact Test (HIT-6™) consists of 6 items designed to measure the impact headaches have on a person's ability to function. Scores from the 6 questions will be added to create a total score. Range of the total score is 36 to 78. Higher scores indicate a greater impact on the subject's quality of life.

This study is for subjects who have been diagnosed with migraine for at least one year and who are currently taking an effective abortive medication(s).

Eligibility

Ages Eligible for Study:

18 Years to 65 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

History of migraines headaches for 1 year and well documented 3 month retrospective history of migraines.

Experience 2-8 migraines per month but not more than 15 headache days per month. There should be at least 48 hours of freedom between headaches.

On effective stable abortive medication(s) for the acute treatment of migraine.

Exclusion Criteria:

Subject in another investigational drug or device study within the last 30 days or is currently in another investigational drug trial.

Use of triptans or ergots for migraine abortive treatment > 2-3 days per calendar week 2 months prior to screening.

Experience 15 or more headache days per month of any kind 2 months prior to screening.

Has another consistent or chronic form of headache.

Unable to stop medications, herbs, vitamins, or minerals used to prevent a migraine from occurring.

Pregnant or nursing women and those of child bearing potential who are not surgically sterile, or 2 years post menopausal, or do not practice 2 combined methods of birth control, unless sexually abstinent, during the trial.

Significant laboratory or electrocardiograms (ECG) abnormalities

Significant medical history including cardiovascular abnormalities.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440518